ROC MED Statistics has extensive experience in supporting medical device development. We offer both clinical and non-clinical solutions tailored to meet the specific needs of our clients. Our deep industry expertise and unwavering commitment to quality position us as the ideal partner to help you achieve your business goals and shape a brighter future.

Leveraging our vast experience in clinical trials and user-centric technologies, we work with clients to optimize their time and budget, ensuring efficient project execution and successful outcomes. Our team has a proven track record of navigating complex regulatory environments, with extensive experience in submissions and interactions with the FDA and other regulatory agencies across the world. Our expertise spans protocol development, FDA meeting representation, interim and final analyses, project rescue operations, and presentation at panel meetings.

At ROC MED Statistics, we prioritize delivering projects on time and within budget. Our meticulous planning ensures adherence to agreed timelines, with the flexibility to make necessary internal adjustments to stay on course.

ROC MED Statistics LLC is dedicated to helping companies navigate the increasingly regulated and demanding landscape of product development and approval. In today’s regulatory and economic climate, maintaining a sharp focus on your objectives is more crucial than ever. We offer a wide range of services to assist companies in achieving their goals, including:

CDx/IVD/LDT Product Development

· Assay development design control

· Verification and validation study protocol

· Statistical analysis plan, and Reporting

· Clinical Trials & Publication Support

· Preparation of Submission Packages

· Interaction with regulatory agencies

Statistical Programming Services

· Production Programming (TLFs: Design of Tables, Listings and Figures)

· Creation of Programming Specifications for ADAM datasets in CDISC format

· Validation of Statistial Output

Data Management Services

· EDC System Selection

· CRF Review, Design and Development

General Statistics

· RWD/RWE planning and analysis

· Data Mining & Pattern Recognition

· Predictive Model Development

· Statistical Inference

· Publication Support